Tissue repair devices and methods

ABSTRACT

Devices and methods for reconnecting or supporting torn, damaged or weak tissue are disclosed. The disclosed embodiments can be used on long slender tissue such as ligaments, tendons, nerves, vessels, intestines, muscles, bones, appendages and any other elongate tissue within the body, of both humans and other animals. The devices can wrap around elongate tissue and is capable of supporting the tissue or keeping two severed ends in close proximity to one another. The devices can be used in addition to or in lieu of sutures. The devices can function similar to a Chinese Finger Trap and are capable of decreasing in diameter upon extension, thus constricting upon the tissue. The multiple coils of the devices can make sufficient surface contact on the ligament or tendon, using friction to keep the device in place, while also allowing access for diffusion of oxygen and nutrients.

RELATED APPLICATIONS

The present application claims benefit of priority under 35 U.S.C.§119(e) of U.S. Provisional Patent Application No. 61/736,000, filedDec. 11, 2012, and entitled “RECOMBINATION AND SUPPORT DEVICES ANDMETHODS FOR INJURED TISSUE,” which is hereby incorporated herein byreference in its entirety.

TECHNICAL FIELD

This disclosure relates generally to the field of surgery. Moreparticularly it relates to devices and methods to support weak tissue orfor moving two regions of tissue towards each other to reconnect orsupport tissue that is separated or at risk of separation.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain suchillustrative embodiments that are depicted in the figures, in which:

FIG. 1A is a perspective view of a tissue repair device, according toone embodiment of the present disclosure.

FIG. 1B is a side view of a tissue repair device, according to oneembodiment, in a relaxed state.

FIG. 1C is a side view of a tissue repair device, according to oneembodiment, in an extended state and having a decreased coil diameterupon extension.

FIG. 2 is a side view of a tissue repair device, according to oneembodiment, encircling severed or injured tissue.

FIG. 3 is illustrates tension distribution within a tissue repair deviceduring extension, in which tension is distributed circumferentially andalleviates tension at the wounded site of the tissue.

FIG. 4 illustrates a side view of a tissue repair device, according toone embodiment, encapsulating frayed tissue.

FIG. 5 is a perspective view of a tissue repair device, according toanother embodiment, having a larger diameter at a first end of thedevice and a smaller diameter at an opposite second end of the device.

FIG. 6 is a perspective view of a tissue repair device, according toanother embodiment, having a smaller diameter at a center portion andlarger diameters towards each end.

FIG. 7 is a perspective view of a tissue repair device, according toanother embodiment, having a larger diameter at a center portion andsmaller diameters towards each end.

FIG. 8 shows various shaped transverse cross-sectional areas of a coilmember of a tissue repair device.

FIG. 9 shows transverse cross-sectional views of various tissue repairdevices, illustrating varying shaped lumens of tissue repair devices.

FIGS. 10A-10D are cross-sectional views of various embodiments of a coilmember of a tissue repair device, showing the coil member with a macroor micro texture on all or part of a surface.

FIGS. 11A-11D are cross-sectional views of a coil member of variousembodiments of a tissue repair device, showing the coil member with acoating on all or part of a surface.

FIG. 12A is a side view of a tissue repair device encircling and engagedwith an elongate tissue.

FIG. 12B is a side view of the tissue repair device of FIG. 12A in anextended state engaging the elongate tissue is it is extended.

FIG. 13A illustrates deployment of a tissue repair device onto a partialor full tissue tear of an elongate tissue by twisting the coil onto theelongate tissue.

FIG. 13B illustrates the tissue repair device of FIG. 13A positioned inplace on injured elongate tissue.

FIG. 13C illustrates the healed elongate tissue after the tissue repairdevice dissolves or is removed.

FIG. 14A illustrates deployment of a tissue repair device by reversingthe twist in the coil, to increase a diameter of the turns of the coilto more easily place the injured elongate tissue within a lumen of thecoil.

FIG. 14B illustrates the tissue repair device of FIG. 14A in place onthe injured elongate tissue.

FIG. 14C illustrates the healed tissue after the tissue repair devicedissolves or is removed.

FIG. 15A illustrates a method of connecting sutures to either end of asevered elongate tissue and threading the sutures through a tissuerepair device.

FIG. 15B illustrates the injured elongate tissue pulled through thetissue repair device of FIG. 15A using the sutures.

FIG. 15C illustrates the injured tissue in place within the tissuerepair device of FIG. 15A.

FIG. 16 is a flow diagram of a manufacturing process for producing atissue repair device, according to one embodiment, by using an injectionmolding system.

FIG. 17 is a flow diagram of a manufacturing process for producing atissue repair device, according to one embodiment, by wrapping anextruded polymer around a heated dowel or heating the polymer andwrapping it around a dowel.

FIG. 18 is a flow diagram of a manufacturing process for producing atissue repair device, according to one embodiment, by wrapping metalaround a heated dowel or heating the metal and wrapping it around adowel.

Other features of the present embodiments will be apparent from theaccompanying drawings and from the detailed description that follows.

DETAILED DESCRIPTION

Soft tissue injuries such as lacerations of ligaments and tendons can berepaired using sutures. However, when the tissue is under stress such astensile stress, high tension can result at discrete suture sites andcause sutures to tear through the tissue. Torn tissue can require arepeat surgery to be repaired. The disclosed tissue repair devices canbe used to effectively ligate and/or support torn or otherwise damagedtissue. The disclosed tissue repair devices distribute tension alongrepaired tissue and thus decrease the risk of injured tissue being tornafter repair.

Soft tissue tears, such as tears of the Patellar and Achilles tendonrupture, can result in “mop ends” or frayed edges at the torn ends.These frayed ends can be time consuming and difficult to suturetogether, particularly in a manner to promote healing of the tear. Thedisclosed tissue repair devices can gather frayed mop ends and promotehealing.

The disclosed tissue repair devices and methods can also be used toconnect or support other elongate tissue within the body such as nervesand blood vessels. Sutures injure tissue in order to remain fixed inplace. The disclosed tissue repair devices and methods of treatment canconnect or support weak, damaged, or severed tissue while causingminimal or no damage to the tissue.

The present disclosure provides tissue repair devices for recombining,reconnecting and/or supporting torn, damaged or weak tissue.Specifically the disclosed devices can be used on elongate, slendertissue such as ligaments, tendons, nerves, vessels, intestines, muscles,bones, appendages and any other elongate tissue within the body. Thedevices can be used in both humans and animals. The present disclosurealso provides methods for recombining, reconnecting or supporting torn,damaged or weak tissue, including administering the disclosed devicesonto damaged tissue. The present disclosure also provides manufacturingprocesses for the creation of a device to reconnect damaged tissue.

The disclosed embodiments offer improved distribution of tensioncompared to sutures to prevent tissue from tearing under stress.

The disclosed embodiments do not need to pierce the tissue to remain inplace.

The disclosed embodiments may reconnect or support tissue that isseparated or at risk of separation.

In accordance with the principles of the present disclosure, thedisclosed embodiments decrease tension at the wound site by distributingtension along the device and alleviating direct tension on the tissue.

The disclosed embodiments can encircle and engage or grip elongatetissue, using principles of friction and constriction, without causingdamage to the tissue, for example, to support the damaged elongatetissue and/or to maintain two separated ends of the elongate tissue inclose proximity to one another. The disclosed embodiments can providemechanical support, stability, and the introduction of biologics such asproteins, cells, and growth factors to injured tissue. The disclosedembodiments may facilitate healing by allowing nutrients and oxygen todiffuse into the tissue through the gaps in the coils. For example, thedisclosed embodiments may be porous, drug-eluting, and/or otherwiseenhanced to promote tissue regeneration and cellular growth of thedamaged tissue.

The disclosed embodiments may facilitate early mobilization of theinjured tissue by stretching and moving with the tissue. The disclosedembodiments may reduce time to repair torn and injured tissue, comparedto suturing and other methods. The disclosed embodiments may be used inconjunction with or in place of sutures.

The disclosed embodiments can be connected directly to soft tissue, andmay not involve mounting to, for example bone, thus, limiting or evenpreventing any damage to the bone growth plate. The disclosedembodiments may enable tendons or ligaments that become frayed andswollen to be enclosed within a coil to more easily slide within thetight sheath. The disclosed embodiments may also facilitate manipulationof the severed tendon through the sheath during surgery.

One embodiment may be connected to soft tissue at a first end and boneat a second end to reduce tension at the soft tissue-bone interface.

The disclosed embodiments can encapsulate frayed mop ends of a ligamentor tendon, thus reducing the need for complex suturing and decreasingrisk of scar adhesion within the tissue sheath.

The disclosed embodiments can constrict upon a suture site so that thetendons can glide more readily within the sheath.

The disclosed embodiments may allow soft tissue to press up or outwardbetween the coils, creating multiple catch points to inhibit or evenprevent the tissue from slipping within the coil.

The disclosed embodiments may decrease in diameter upon extension,constricting on the elongate tissue and remaining in place even duringextension. In particular, a lumen through the device may decrease indiameter upon extension. This decrease in diameter upon extension, canaccommodate the decrease in diameter of elongate tissue that may occurwhen the elongate tissue is extended, thus allowing the device tomaintain proper contact and engagement during extension and relaxationof the elongate tissue. The disclosed embodiments may employ principlesof friction and constriction to remain in place and maintain contactwith injured tissue.

The disclosed embodiments may increase in diameter during relaxedstates, allowing for the least constriction and maximum diffusion ofnutrients to the damaged tissue within the device.

The disclosed embodiments can be made of biodegradable polymers that canbe broken down by the body after the injured tissue is sufficientlyhealed, allowing the native tissue to return to its normal state.Examples of polymers and constituents of co-polymers that can be usedare polycaprolactone, polyurethane, polylactic acid, polyglycolic acid,polyvinyl alcohol, polyvinylpyrrolidone, polyester, andpoly(hydroxyalkanoate).

The disclosed embodiments can be made of naturally biodegradeablematerials that can be broken down by the body after the injured tissueis healed, allowing the native tissue to return to its normal state.Examples of natural materials that can be used are extracellular matrixproteins such as collagen, fibronectin, fibrinogen, lamanin, elastin,keratin and polysaccharides, such as starch, cellulose, and chitosan.

The disclosed embodiments can also be infused with, or otherwise includenutrients, supplements, medicaments, sugars, growth factors, proteins,and/or hormones, which may promote and enhance healing of the elongatetissue. For example, as the biodegredable polymers and/or naturalmaterials may include elements to promote tissue growth and/or healingthat may be released as the biodegradeable polymers and/or naturalmaterials are broken down by the body.

The disclosed embodiments can be made of non-biodegradable polymers thatwill remain in place to continue to support the injured tissue. Examplesof polymers and constituents of co-polymers that can be used arepolytetrafluoroethylene, polyurethane, polystyrene, polycarbonate,polyester, polysulfone, polyethylene terephthalate, polyethylene,polypropylene, polyurethane, silicone, polydimethylsiloxane,polymethylmethacrylate, and polyhydroxyethyl methacrylate, andpolyetheretherketone.

The disclosed embodiments can be made of metals or metal alloys thatwill remain in place to continue to support the injured tissue. Examplesof metals or constituents of metal alloys that can be used includenitinol, stainless steel, cobalt, chromium, titanium, platinum, iridium,tungsten, tantalum, aluminum, vanadium, molybdenum, silver, copper,silicon, and tin.

The disclosed embodiments can be made of metals or metal alloys that candegrade. Examples of metals or components in metal alloys that can beused include iron, magnesium, silicon, cobalt, tungsten, boron, carbon,lead, and sulfur.

The disclosed embodiments can be made of a ceramic that can bedegradable or non-degradable. Examples of ceramics includehydroxyapetite, bioglass, calcium phosphate, titanium nitride, tungstencarbide, titanium carbon nitride, aluminas, SiO₂, Na₂O, CaO, P₂O₅ andzirconia.

The disclosed embodiments may include deployment during surgery bypositioning the open end of the coil at one of the ends onto the tissueand twisting the coil onto the tissue much like twisting a key ring ontoa key.

The disclosed embodiments may involve twisting the coil onto theligament or tendon, which may allow the device to be deployed at a siteof a partial tear and complete tear of the injured elongate tissue.

The disclosed embodiments may include deployment during surgery bysuturing each end of the severed tissue and using the sutures to pullthe tissue into the lumen of the coiled device.

The disclosed embodiments may include deployment by reversing the coilof the device to increase the diameter of the coil to more easily allowinsertion of wounded tissue.

The presently disclosed embodiments of devices may be created usinginjection molding processes.

The presently disclosed embodiments of devices can be created bywrapping extruded polymer around a dowel.

The presently disclosed embodiments of devices can be created bywrapping metal around a dowel.

Certain embodiments of the present disclosure will now be discussed withreference to the accompanying drawings and reference numerals providedtherein so as to enable one skilled in the art to practice the presentinvention. The drawings and descriptions are examples of various aspectsof the invention and are not intended to narrow the scope of the claimsto the inventions. Also, for the sake of simplicity, the illustrateddevices and tissue may be represented as cylindrical in shape, howevereach of these embodiments can be altered to accommodate a device andtissue shape that is not cylindrical.

FIG. 1A is a perspective view of a tissue repair device 100, accordingto one embodiment. The tissue repair device 100 comprises a coil orspiral shape formed by a coil member 103 arranged in a coil or spiral toform a plurality of interconnected turns 106 that creates a lumen 105 atits center. The tissue repair device 100 can have a length of X andspacing of Y between the turns 106 of the coil 105 of the device 100.The spacing Y between the turns 106 can vary along the length X of thetissue repair device 100. The coil member 103 has a thickness Z, whichcan vary along the length X of the device 100. A diameter W of the turns106 of the coil member 103 can be varied along the length X of thedevice 100, which correspondingly varies the diameter of the lumen 105.FIG. 1B shows a tissue repair device 100, according to one embodiment,in a relaxed state in which the coil has a first (relaxed) coil diameterW_(R) and a first relaxed length X_(R). FIG. 1C shows the tissue repairdevice 100 of FIG. 1B in an extended state and illustrates a resultantdecrease in coil diameter W, to a second (extended) coil diameter W_(E)and an extended length X_(E), as seen compared to the relaxed coildiameter W_(R) and relaxed coil length X_(R). The tissue repair device100 may approximate or function in a manner similar to a “Chinese fingertrap” in concept by reducing in diameter upon extension, allowing thedevice to accommodate any decrease in diameter seen in the elongatetissue such as a ligament or tendon during extension.

The coil member 103 may be formed of a biodegradable polymers and/ornatural materials that can be broken down by the body after the injuredtissue is sufficiently healed, allowing the native tissue to return toits normal state. Examples of polymers and constituents of co-polymersthat can be used are polycaprolactone, polyurethane, polylactic acid,polyglycolic acid, polyvinyl alcohol, polyvinylpyrrolidone, polyester,and poly(hydroxyalkanoate). Examples of natural materials that can beused are extracellular matrix proteins such as collagen, fibronectin,fibrinogen, lamanin, elastin, keratin and polysaccharides, such asstarch, cellulose, and chitosan.

The coil member 103 can be infused with, or otherwise include nutrients,supplements, medicaments, sugars, growth factors, proteins, and/orhormones, which may promote and enhance healing of the elongate tissue.For example, as the biodegredable polymers and/or natural materials mayinclude elements to promote tissue growth and/or healing that may bereleased as the biodegradeable polymers and/or natural materials arebroken down by the body.

Portions (or all) of the coil member 103 may be porous. The porosity ofthe coil member 103 may promote tissue growth and/or cellular in-growth,which may enhance engagement or securement of the tissue repair device100 relative to the injured tissue and/or surrounding tissue. Porosityof the coil member may also contribute to coil compliance anddegradation rate. As will be described below, coating may be employed toenhance or reduce porosity of the coil member 103.

FIG. 2 shows a tissue repair device 200 encircling an injured portion201 of an elongate tissue 202. The tissue repair device 200 may employprinciples of friction and constriction to maintain engagement with andsecure the injured portion 201 of the elongate tissue 202 in place, andto limit slipping of the device 200 along the tissue 202. The tissuerepair device 200 may employ principles of friction and/or constrictionto remain fixed in place relative to the elongate tissue 202. Forexample, sutures may not be needed to maintain the device 200 in a fixedposition relative to the elongate tissue 200.

FIG. 3 shows a tissue repair device 300, according to one embodiment.The tissue repair device 300 is shown encapsulating injured tissue 304.The tension of the tissue repair device 300 during extension is equallydistributed circumferentially 305 around the device, resulting inconstriction of the tissue repair device 300 to engage or grip theelongate tissue. This circumferential tension distribution reduces therisk of tearing tissue that is in contact with the device 300,particularly compared to sutures having tension highly concentrated at asingle site of insertion. The tension in the device 300 (andcorresponding constriction of the device 300) may be less toward theoutside ends 303 and greater at the center 301 of the device 300. Theincreased tension at the center of the device 301 alleviates the tensionexperienced by the injured tissue 304 at its center 302, reducing therisk of tissue separation and/or tearing of sutures at the injured site.The illustrated tissue repair device 300 may be used in conjunction orin lieu of sutures to connect together injured tissue, such as free (orseparated) ends of torn (or partially torn) elongate tissue.

FIG. 4 shows a tissue repair device 401 enclosing or encircling frayedends 402 of an elongate tissue 400 circumferentially. The illustratedtissue repair device 401 can gather frayed ends 402 by encapsulation,removing a need for complex suturing to gather the frayed ends. Thefrayed ends 402 are gathered within a lumen of the tissue repair device.The tissue repair device 401 may maintain the frayed ends 402 in closeproximity to one another to facilitate and enhance healing of theelongate tissue 400.

FIG. 5 shows a tissue repair device 500, according to anotherembodiment. The illustrated tissue repair device 500 may have a largercoil diameter W₁ on a first end 501 of the device 500 that can be variedby A and a smaller diameter W₂ at a second opposing end 502 that can bevaried by B. This design may accommodate changes in a diameter of thetissue along its length X.

FIG. 6 shows a tissue repair device 600, according to anotherembodiment. The illustrated tissue repair device 600 may have a smallercoil diameter W₁ towards a center portion 603 that can be varied by Xand a larger coil diameter W₂ that can be varied by Y at a first end 601and the same or different larger coil diameter W₃ that can be varied byZ at an opposing second end 602.

FIG. 7 shows a tissue repair device 700, according to anotherembodiment. The illustrated tissue repair device may have a larger coildiameter W₁ that can be varied by X at a center portion 703 of thedevice 700 and a smaller coil diameter W₂ that can be varied by Y at afirst end 701 and the same or different smaller coil diameter W₃ thatcan be varied by Z at the opposing second end 702.

FIG. 8 shows various shaped cross sectional areas 800-810 of a coilmember (see coil member 103 of FIG. 1) of a tissue repair device.Varying cross sectional shapes can be used to maintain the tissue repairdevice in contact with the tissue and to enable the proper movement ofthe device within the body. The dimensions of the cross sectional areas800-810 can be altered to best suit the implant situation. The variousexamples illustrated are merely representative, and are not in any waylimiting of the scope of the present disclosure.

FIG. 9 shows transverse cross sectional areas 900-910 of various tissuerepair device, illustrating that varying shaped lumen may be defined bythe tissue repair device and can be used to maintain the tissue repairdevice in contact with the tissue and to enable the proper movement ofthe device within the body. The dimensions of the cross sectional areas900-910 can be altered to best suit the implant situation. The variousexamples illustrated are merely representative, and are not in any waylimiting of the scope of the present disclosure.

FIG. 10A-D shows example magnified cross sectional views of a coilmember 1000, according to various embodiments, to illustrate that thecoil member 1000 can be textured on all surfaces 1001, as shown in FIG.10A. The texture may provide one of nano-, micro-, meso- andmacro-textured surfaces on the coil member 1000. The coil member 1000can have texture only along a top surface 1002 or outer surface 1002, asshown in FIG. 10B, thereby effect (e.g., engaging) the surroundingtissue and environment. The coil member 1000 can have texture only alongthe bottom surface 1003, or inner surface 1003, as seen in FIG. 10C,thereby effect (e.g., engaging) the elongate tissue to be repaired. FIG.10D shows different texture along the top or outer surface 1004 and thebottom or inner surface 1005 of the coil member 1000. Textured surfacescan increase surface area, which may enable increased friction andthereby limit slipping of a device of along tissue to be repaired and/oralong surrounding tissue. The surface texture may also increase ordecrease tissue adhesion as appropriate. Surface texture can be used asappropriate to enhance, or even optimize functionality and ability torepair or support injured tissue. The coil member 1000 may also besmooth, or substantially free of surface texture, on all surfaces.

FIG. 11A shows a cross sectional area of the coil member 1100illustrating the coil member 1000 can include a coating 1101 on allsides 1102. FIG. 11B shows the coil member 1100 with a coating 1102 onlyalong the top or outer surface that affects the outside of the device ortissue surrounding the device. FIG. 11C shows the coil member 1100 witha coating 1103 only along a bottom or inner surface that affects theinside of the device adjacent to the tissue to be repaired. FIG. 11Dshows the coil member 1100 with a coating 1105 along the top our outersurface 1105 and a different coating 1104 along the bottom or innersurface. The foregoing described coatings can comprise altered surfacechemistry, chemical coatings, mineral coatings, biological coatings suchas proteins, cells, sugars, lipids, etc., and cells such as stem cells,fibroblasts, chondrocytes, epithelial cells, endothelial cells, smoothmuscle cells, macrophages, etc. These coatings can assist in celladhesion, tissue regeneration, and preventing cell adhesion and tissuegrowth. Coatings can be used to optimize this device's functionality andability to repair or support injured tissue.

In one embodiment, the coatings described above may be porous. A poroussurface of the coiled member may promote cellular in-growth, which mayfurther stabilize and ensure fixation of the tissue repair devicerelative to surrounding tissue. In another embodiment, the coiled member1100 itself may be porous and the coating may reduce porosity wherecellular in-growth may not be desired.

FIG. 12A shows a tissue repair device 1200, according to one embodiment.The tissue repair device 1200 is disposed around and engaging anelongate tissue 1202. In FIG. 12A, injured tissue 1203 is shown pressingup (or out) between the turns 1206 of the device 1200. If a diameter ofthe device 1200 is smaller than a diameter of the elongate tissue 1202,then portions of the injured tissue 1203 may press up (or out) betweeneach turn 1206 of the device 1200. The buckling or pressing up (or out)of the portions of the tissue 1203 between each turn 1206 of the tissuerepair device 1200 may create multiple catch points that may prevent thetissue 1202 and device 1200 from sliding relative to each other and/orpast one another.

FIG. 12B shows the buckling or pressing up of tissue 1203 between eachturn 1206 of the device 1200 during extension of the tissue repairdevice 1200 and elongate tissue 1202. In the case of ligaments ortendons that do not have vasculature, this construction and buckling maynot limit or prevent diffusion of nutrients in the tissue. Also onlyslight buckling may be sufficient that may not greatly reduce theoverall length of the tissue. If the tissue to be repaired is a vessel,such as a blood vessel with a hollow lumen, then the diameter of thedevice can be adjusted so that no buckling of the tissue will occur andthe device may be used as a support.

FIG. 13A Shows a method of deploying a device 1300 onto tissue 1302 thatis partially or fully torn. An end 1306 of the coil member 1303 of thecoil device 1300 can be placed on the tissue where there is an open endof the coil 1300. The device 1300 can be twisted in the direction shownby the arrows 1301 onto the tissue much like a key ring onto a key,twisting the device 1300, for example one turn 1304 at a time. FIG. 13Bshows the device 1300 in place on the injured tissue 1302. An aspect ofthe disclosed embodiments, is that due to the coiled design, theembodiments can be placed onto tissues that are not completelylacerated, but can be twisted onto partially intact tissue. FIG. 13Cshows healed tissue 1305, after the device 1300 dissolves or is removed.

As described above, a coil member 1303 of the tissue repair device 1300may be formed of a biodegradable polymers and/or natural materials thatcan be broken down by the body after the injured tissue is sufficientlyhealed, allowing the native tissue to return to its normal state. Thecoil member 1303 can be infused with, or otherwise include nutrients,supplements, medicaments, sugars, growth factors, proteins, and/orhormones, which may promote and enhance healing of the elongate tissue.For example, as the biodegredable polymers and/or natural materials mayinclude elements to promote tissue growth and/or healing that may bereleased as the biodegradeable polymers and/or natural materials arebroken down by the body. Eventually the entire coil member 1303 maybreak down and/or be absorbed by the body, as shown in FIG. 13C.

FIG. 14A shows a method where a device 1400 can be twisted in thereverse direction of the coil member 1403 on either end in order toincrease the diameter of the turns of the coil member 1403, enabling alarger space (lumen 1405) to insert the target injured elongate tissue1402 to be repaired. FIG. 14A illustrate first and second free ends oftorn elongate tissue 1402 being inserted into the lumen 1405 of thedevice 1400 such that the coil member 1403 can constrict around the freeends and draw and or maintain them together in close proximity. FIG. 14Bshows the device 1400 in place on injured tissue 1402. The coil member1403, and therefore the lumen 1405, of the device 1400 is constrictedtoward the relaxed state in engagement gripping the elongate tissue1402. FIG. 14C shows healed tissue 1404 after the device 1400 dissolvesor is removed.

FIGS. 15A and 15B show a method of threading sutures connected to tissuethrough a device 1500. FIG. 15A shows a pair of sutures 1504 that aresutured to each severed end of injured tissue 1502. The sutures 1504 canbe threaded into and/or through a lumen 1505 of a tissue repair device1500. FIG. 15B shows a method of threading the available end (or freeend) of the sutures 1504 into and through a lumen the device 1500 andpulling the sutures 1504 through the device in order to pull theattached severed tissue 1502 into the device 1500. FIG. 15C showssevered tissue 1502 within and encircled by the device 1500.

FIG. 16 is a flow diagram of a manufacturing process for producing adevice, according to one embodiment, by using an injection moldingsystem. First a polymer (or other material of manufacture, e.g., metal)may be dissolved or melted 1600. Next the polymer is injected into amold 1601. Next the polymer can be modified using physical or chemicalprocesses 1602. Next the polymer is allowed to set 1603. Next thepolymer can be removed from the mold and further modified using physicalor chemical processes 1604. Next quality assurance testing can beperformed on the device 1605. Lastly, sterilization and packaging may beperformed 1606.

FIG. 17 is a flow diagram of a manufacturing process for producing adevice, according to one embodiment of the present disclosure, bywrapping an extruded polymer around a heated dowel or heating thepolymer and wrapping it around a heated or non-heated dowel. First thepolymer is prepared 1700 by being dissolved, melted, etc. Next thepolymer is extruded 1701. Next the polymer is wrapped around a heateddowel 1702. Alternatively the polymer can be heated and wrapped around aheated or non-heated dowel 1702. Next the polymer is allowed to set andmay be modified using physical or chemical processes 1703. The polymermay be removed from the dowel 1704. The polymer may be further modifiedusing physical or chemical processes 1705. Quality assurance testing maybe performed on the device 1706. Sterilization and packaging may beperformed 1707.

FIG. 18 is a flow diagram of a manufacturing process for producing adevice, according to the present disclosure, by wrapping metal around aheated dowel or heating the metal and wrapping it around a heated ornon-heated dowel. First the metal is prepared 1800. Next the metal iswrapped around a heated dowel 1801. Alternatively the metal can beheated and wrapped around a heated or non-heated dowel 1801. Next themetal is allowed to set and can be subsequently modified using physicalor chemical processes 1802. Next the metal can be removed from the doweland further modified using physical or chemical processes 1803. Nextquality assurance testing can be performed on the device 1804. Lastly,sterilization and packaging may be performed 1805.

Additional embodiments include any suitable combination of the featuresdepicted in the drawings. Accordingly, although a specific permutationmay not be illustrated as a stand-alone embodiment in any of thedrawings, all of the features are shown and described in the drawingssuch that the present drawings provide full support for these additionalembodiments.

The disclosed embodiments may comprise a device with a center shape thatcan accommodate the shape of the tissue to be ligated or supported.These shapes include but are not limited to: circle, elliptical, square,rectangle, triangle trapezoid, or any combination of these shapes thatmay change shape along the length of the device. For example one end canbegin as a circle cross section, but end as an ellipsoid cross section.

The disclosed embodiments may use the number and tightness of coils tocontrol the grip onto the tissue

The disclosed embodiments may use principles of friction andconstriction to maintain contact with tissue.

The disclosed embodiments may comprise a coil member used to make a coilthat can have various shaped cross-sectional areas including circle,elliptical, square, rectangle, triangle trapezoid, etc., or anycombination of these shapes and where these shapes can change along thelength of the coil member.

The disclosed embodiments may comprise a coil member that can be made ofvarying thicknesses of material that can vary along the length of thedevice.

The disclosed embodiments where the device comprises an elongate hollowcoiled member of biocompatible, surgically implantable material. Themember having a first and second end, with the device being open at bothends.

The disclosed embodiments may comprise a method for treating weakened,damaged, and partially or completely lacerated tissue, wherein thismethod comprises obtaining a tissue repair device and accessing injuredtissue within the body.

One of the disclosed embodiments may be a method of manufacturing atissue repair device, comprising: preparing a biocompatible material;forming the biocompatible material into a coil comprising a series ofinterconnected turns defining a lumen through the coil, the lumen beingopen at both ends and configured to receive and encircle an elongatetissue to be repaired, wherein the material in a hardened state isconfigured to allow the coil to be extendable to increase a distancebetween adjacent turns of the plurality of turns and increase a lengthof the coil and to decrease a diameter of one or more of the turns ofthe plurality of turns proportional to extension of the length to moretightly engage an elongate tissue disposed within the lumen to decreasetension at a wound site of the elongate tissue by distributing tensionalong a length of the coil; and allowing the biocompatible material toset.

The method of manufacture may further include texturing an inner surfaceof the coil to enhance engagement of the inner surface with tissue to berepaired and limit sliding of the tissue repair device relative to thetissue to be repaired.

The examples and embodiments disclosed herein are to be construed asmerely illustrative and exemplary, and not a limitation of the scope ofthe present disclosure in any way. It will be understood to those havingskill in the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the disclosure herein. For example, any suitablecombination of various embodiments, or the features thereof, iscontemplated. For example, any of the devices disclosed herein caninclude features of other embodiments. The scope of the invention istherefore defined by the following claims and their equivalents.

What is claimed is:
 1. A tissue repair device comprising: a coilcomprising a plurality of interconnected turns in series, the coilformed of an elongate coil member of biocompatible material, the coilmember having a first end and a second end and configured in a spiralpattern to form the series of interconnected turns of the coil anddefine a lumen through the coil, the lumen being open at both ends andconfigured to receive and encircle an elongate tissue to be repaired,the coil being extendable to increase a distance between adjacent turnsof the plurality of turns and increase a length of the coil, whereineach turn of the plurality of the turns of the coil has a first diameterwhen the coil is in a relaxed state, the diameter configured to engagethe elongate tissue in the relaxed state and configured to reduce to asecond diameter smaller than the first diameter when the coil is in anextended state to more tightly engage the elongate tissue, wherein turnsof the coil at a first end of the coil are configured to engage a firstportion of the elongate tissue and turns of the coil at a second end ofthe coil engaging a second portion of the elongate tissue such that atension on the elongate tissue pulling the first portion in directionaway from the second portion of the elongate tissue extends the coil,thereby reducing the diameter of turns of the plurality of turns of thecoil member to more tightly engage the elongate tissue and decreasetension at a wound site of the elongate tissue by distributing tensionalong a length of the coil.
 2. The tissue repair device of claim 1,wherein the plurality of turns of the coil member define a lumenconfigured to receive and encircle an elongate tissue of human andanimal origin that is one of a ligament, a tendon, a nerve, a vessel, anintestine, a muscle, an appendage, and a bone.
 3. The tissue repairdevice of claim 1, wherein the lumen has a first open end and a secondopen end, the first open end being one of circular, elliptical, square,rectangular, triangular, and trapezoidal and the second open end beingone of circular, elliptical, square, rectangular, triangular, andtrapezoidal.
 4. The tissue repair device of claim 1, wherein theelongate coil member is formed of one of a metal, a polymer, and aceramic.
 5. The tissue repair device of claim 1, wherein the coil memberis biodegradable.
 6. The tissue repair device of claim 5, wherein thecoil member further comprises one or more of a medicament and a nutrientto enhance tissue regeneration.
 7. The tissue repair device of claim 1,wherein the coil member is drug-eluting to promote tissue regeneration.8. The tissue repair device of claim 1, wherein the coil member isporous to promote cellular in-growth.
 9. The tissue repair device ofclaim 1, wherein spacing between adjacent turns of the plurality ofturns of the coil, in the relaxed state, varies along a length of thecoil.
 10. The tissue repair device of claim 1, wherein a transversecross-sectional area of the lumen through the coil varies along a lengthof the coil.
 11. The tissue repair device of claim 1, wherein the crosssectional area of the lumen of the coil at a first end is smaller thanat a second end.
 12. The tissue repair device of claim 1, wherein thecross sectional area of the lumen of the coil is smaller at a centerregion of the coil and larger towards ends of the coil.
 13. The tissuerepair device of claim 1, where the cross sectional area of the lumen ofthe coil is larger in the center of the coil and smaller towards the twooutside ends.
 14. The tissue repair device of claim 1, wherein athickness of the coil member varies along a length of the coil.
 15. Thetissue repair device of claim 1, wherein a transverse cross-section ofthe coil member is one of circular, elliptical, square, rectangular,triangular, trapezoidal, or a combination and the second open end beingone of circular, elliptical, square, rectangular, triangular, andtrapezoidal.
 16. The tissue repair device of claim 1, wherein the coilmember has one of nano-, micro-, meso- and macro-textured surfaces. 17.The tissue repair device of claim 1, wherein the coil member is coatedwith a coating comprising one or more of cells, a chemical, a mineral, anatural polymer, a synthetic polymer, a protein, a carbohydrate, and asugar.
 18. The tissue repair device of claim 17, wherein the coating isapplied to an inner surface of the coil.
 19. The tissue repair device ofclaim 1, wherein the coil member is formed by wrapping a polymer arounda dowel and allowing the polymer to cure.
 20. The tissue repair deviceof claim 1, wherein the coil member is configured to remain engagedaround the elongate tissue, with an inner surface of the plurality ofturns engaging the elongate member using principles of friction andconstriction, independent of sutures through the elongate tissue.
 21. Amethod of supporting tissue, the method comprising: obtaining a tissuerepair device comprising a coil formed by an elongate coil member ofbiocompatible material having a first end and a second end andconfigured in a spiral pattern to form a series of interconnected turnsand to define a lumen through the coil member being open at both ends toreceive, encircle, and engage target elongate tissue to be treated;accessing within the body the target elongate tissue; and positioningthe tissue repair device with the coil around the target elongatetissue, with the target elongate tissue disposed through the lumen withan inner surface of the series of interconnected turns engaging thetarget elongate tissue.
 22. The method of claim 21, wherein supportingtissue comprises connecting together a first free end and a second freeend of a torn elongate tissue, the method further comprising: drawingtogether the first free end and the second free end of the torn elongatetissue to be connected, and wherein positioning the tissue repair deviceincludes positioning the first and second free ends to be connectedwithin the lumen with an inner surface of the series of interconnectedturns engaging the target elongate tissue and maintaining the first freeend and the second free end of the target elongate tissue in closeproximity to each other.
 23. The method of claim 21, wherein the coil isextendable from a relaxed state to an extended state and each turn ofthe series of interconnected turns has a first diameter when in a therelaxed state and a second smaller diameter when in the extended state.24. The method of claim 21, wherein the tissue repair device isconfigured such that tensile stress on the elongate tissue extends thecoil to the extended state and thereby distributes tension resultingfrom the tensile stress along the target elongate tissue through alength of the coil.
 25. The method of claim 21, wherein the tissuerepair device is configured such that a first end can be mounted to abone and a second end can encircle soft tissue and thereby relievetension at the bone-soft tissue interface.
 26. The method of claim 21,wherein positioning the tissue repair device comprises: engaging a firstend of the coil member of the tissue repair device with the targetelongate tissue; and twisting the coil member of the tissue repairdevice onto the target elongate tissue to position the target elongatetissue through the lumen with an inner surface of the series ofinterconnected turns engaging the target elongate tissue.
 27. The methodof claim 21, wherein positioning the tissue repair device comprises:twisting the coil member in a direction opposite a direction of thespiral pattern to increase a diameter of one or more turns of the seriesof interconnected turns to allow positioning of the coil around thetarget elongate tissue, with the injured tissue disposed within thelumen of the tissue repair device and an inner surface of the series ofinterconnected turns engaging the target elongate tissue.
 28. The methodof claim 21, wherein positioning the tissue repair device comprises:attaching sutures to ends of the elongate tissue to be joined andpassing a free end of the sutures that are not attached to elongatetissue through the tissue repair device in opposite directions andpulling the ends of the elongate tissue into the tissue repair device.29. A method of connecting tissue, the method comprising: obtaining atissue repair device comprising a coil formed by an elongate coil memberof biocompatible material having a first end and a second end andconfigured in a spiral pattern to form a series of interconnected turnsand to define a lumen through the coil member being open at both ends toreceive, encircle, and engage target elongate tissue to be treated;accessing within the body the target elongate tissue; drawing together afirst free end and a second free end of the target elongate tissue to beconnected; and positioning the tissue repair device with the coil aroundthe target elongate tissue with the target elongate tissue, includingthe first and second free ends to be connected, disposed within thelumen with an inner surface of the series of interconnected turnsengaging the target elongate tissue and maintaining the first free endand the second free end of the target elongate tissue in closeproximity.